Why apply as a participant?

Scientific clinical trials are performed with human subjects to evaluate the safety and efficacy of new treatment methods and drugs. The decision to participate in clinical trial is made voluntarily by the subject themselves, with the individual making their own choice and decision as to whether they wish to participate in a clinical trial. Once the subject has made their decision to participate, the subject signs an ‘Informed Consent Form’ and the CCBR doctor provides comprehensive information of what is required by the subject during the clinical trials, detailing possible risks and benefits of the trial.

At this time we answer any questions the subject may have. Clinical trials are conducted following the rule that the subject’s interests and safety are paramount and beyond the public and scientific interests of the trial. Moreover, the subject’s personal rights are secured and his/her safety and well-being are guaranteed as well as assured reliable clinical trial results. Clinical trials are conducted following the Guideline for Good Clinical Practice and ethical principles outlined in Declaration of Helsinki.

The clinical trial phases are the following:

• Phase I: evaluation of investigational medication safety

• Phase II: examination of the medication efficacy

• Phase III: further examination of the medication and treatment efficacy verification in multiple sites globally

• Phase IV: Collection of information on medication effects when safe and effective medication is already widely used for treatment

The clinical trial subject receives free of charge treatment with a new medication during clinical trial. Each subject is under continuous care of qualified specialist team (physicians and nurses) during the trial period. The State Medicines Control Agency issues the permission to conduct clinical trial after receiving the positive opinion by local Bioethics Committee. The institutions mentioned above protect subjects’ interests and monitor the process of clinical trials.

Participating on a Clinical Trial As a participant or ‘study subject’ in a clinical trial, you get some benefits like a full medical examination. CCBR appreciates that when you become a study subject you offer your time and consent to participate on a trial. We assume and understand you will have many questions and we sit with you to discuss and answer these and also detail what will occur over the duration of the study. The information we share will hopefully provide clarity and all the answers to enable you to decide positively that you wish to participate on the clinical study. Together our actions will give other people benefits in the future as new drugs come onto the market across different diseases and conditions.

Medical examinations at CCBR can for example consist of:

• Measurement of bone density

• Radiographs of the spine

• Mammography

• Gynaecological examination with ultrasound and pap smears

• Measurement of heart activity (ECG)

• Measurement of health parameters in blood and urine samples

• Medical Interview and survey

• Blood Pressure Measurements